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Found 1 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

4631 DUO DELIVERY SYSTEM

Manufacturer

Date Cleared

2000-05-03

(37 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K020833,K132315

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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AI/ML Overview

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